BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-1800

    MDR report key: 7275653 · Received February 15, 2018

    Report

    Report Number
    8031673-2018-00069
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 16, 2018
    Report Date
    February 15, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. DEVICE EVALUATION BY MANUFACTURER: ON 16-JAN-2018 A FIELD SERVICE ENGINEER (FSE) FOLLOWED-UP OVER-THE-PHONE AND CONFIRMED THAT THE CUSTOMER WAS ABLE TO GET THE AIA-1800 RUNNING AFTER PRIMING THE SUBSTRATE LINE. NO FURTHER ACTION WAS REQUIRED BY THE FSE. THE CUSTOMER REPORTED THAT THE AIA-1800 WAS OPERATING WITHOUT ANY ERRORS AND IS BEING ABLE TO RUN QUALITY CONTROLS AND PATIENT SAMPLES. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE G8, SERIAL NUMBER (B)(4), FROM (B)(6) 2016 THROUGH (B)(6) 2018. THERE WERE NO OTHER SIMILAR EVENTS REPORTED DURING THE SEARCHED PERIOD. THE AIA-1800 OPERATOR'S MANUAL UNDER 12. APPENDIX 3: FLAGS STATES THE FOLLOWING REGARDING CE AND DL FLAGS: 12.5.4 CE INDICATES CALCULATION ERROR DUE TO USE OF APPROXIMATE EXPRESSION FOR CALIBRATION CURVE. ->CHECK CALIBRATION CURVE AND RESCHEDULE ASSAY OPERATION. PRINT, DISPLAY (RATE VALUE): OUTPUTS OBTAINED VALUE PRINT, DISPLAY (CONCENTRATION VALUE): BLANK RS232C OUTPUT (CONCENTRATION VALUE): FOLLOW THE "FLAG 1" SETTING OF THE UTILITY-HOST SCREEN RS232C OUTPUT (FLAG): A 12.7.3 DL INDICATES MALFUNCTION IN DETECTOR UNIT OR SUBSTRATE DISPENSE FAILURE. ->CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVE. PRINT, DISPLAY (RATE VALUE): OUTPUTS OBTAINED VALUE PRINT, DISPLAY (CONCENTRATION VALUE): BLANK. RS232C OUTPUT (CONCENTRATION VALUE): FOLLOW THE "FLAG 1" SETTING OF THE UTILITY-HOST SCREEN RS232C OUTPUT (FLAG): A THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO THE SUBSTRATE LINE REQUIRING PRIMING.

    Additional Manufacturer Narrative · 0

    (B)(4) PER EXEMPTION NUMBER E2017013. CORRECTED DATA: DEVICE EVALUATION BY MANUFACTURER: A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE AIA-1800, SERIAL NUMBER (B)(4), FROM 16-DEC-2016 THROUGH 16-JAN-2018. THERE WERE NO OTHER SIMILAR EVENTS REPORTED DURING THE SEARCHED PERIOD.

    Description of Event or Problem · 0

    ON (B)(6) 2018 A CUSTOMER REPORTED GETTING DL AND CE FLAGS WHILE RUNNING QUALITY CONTROLS AND PATIENT SAMPLES WITH THE AIA-1800 INSTRUMENT. THE CUSTOMER IS UNABLE TO RUN PATIENT SAMPLES ON ALPHA-FETOPROTEIN (AFP). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR AFP. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116075 AIA-1800 AIA-1800 KHO TOSOH CORPORATION AIA-1800

    Patients

    Seq Age Sex Outcome Treatment
    1